The first patient in the nation to have the MitraClip® procedure following last week's approval from the U.S. Food and Drug Administration was Pearl Segal, 83, of Phoenix. Segal was diagnosed two years ago with mitral valve regurgitation, a backward flow of blood in the heart caused by a leaky heart valve.

The procedure was performed by Saibal Kar, MD, the Heart Institute's director of Cardiovascular Intervention Center Research. Kar has performed more MitraClip procedures than any other U.S. physician, according to manufacturer Abbott.

Mitral regurgitation is a debilitating, progressive and life-threatening disease that affects more than 4 million in the United States, raising their risk of heart failure, irregular heartbeats, stroke and death. Medication can manage their symptoms, but medication does not stop the progression of mitral regurgitation. But Segal, like many other elderly patients with mitral valve regurgitation, was too frail to undergo open-heart mitral valve surgery, which is the standard-of-care treatment.

Before undergoing the procedure, Segal would get out of breath merely walking down the hall of her home. Just hours after her 45-minute mitral valve procedure Nov. 4, Segal's son, David, said, "her color is better, she's not getting out of breath and she's smiling."

Pearl Segal said undergoing the mitral procedure was much easier than her 2009 experience with open-heart surgery to fix an unrelated heart condition. That surgery required 10 days of hospitalization followed by two weeks of cardiac rehabilitation and a month of in-home nursing. Because of Segal's frailty and other health conditions, she was not a candidate for open-heart valve repair.

"I won this time," she said as she prepared to go home the day following her procedure. "This is better than winning the lottery."

"Mitral valves can become dysfunctional for several reasons, including age," said Kar. "But, as we age, we face higher risk from open-heart surgery. Catheter-based, minimally invasive heart procedures are a way we can add years to life and life to years."

During clinical trials, Kar and other Cedars-Sinai Heart Institute physicians performed more catheter-based mitral valve repairs than any other U.S. medical center. Kar receives compensation from Abbott for teaching clinicians how to implant the MitraClip device.

During the procedure, the MitraClip device is delivered to the heart through the femoral vein, a blood vessel in the leg, and once implanted, allows the mitral valve to open and close correctly without leaking, thereby relieving symptoms and improving patient quality of life. Patients undergoing MitraClip treatment typically experience short recovery times and short hospital stays.

"This device offers new hope for thousands of patients with leaky valves worldwide," said Eduardo Marbán, MD, PhD, director of the Cedars-Sinai Heart Institute. "We are proud to have been the leading site in the clinical trials that led to approval, and we look forward to offering this innovative therapy to all those in need."